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Chapter 11 Downstream Processing - Biomanufacturing

2016 Montgomery County Community College Chapter 11 Downstream Processing 424 Chapter 11 - Downstream Processing Objectives This Chapter provides an overview of Downstream Processing . After completing this Chapter , students will be able to: Describe the general elements of the Downstream purification process for a typical monoclonal antibody-based therapeutic, starting with the bioreactor harvest pool and finishing with pre-formulation, pure drug product. Explain the overall goals of the purification process from the standpoint of purity, yield, and efficiency as well as the general strategies employed to achieve these goals.

Intermediate purification: the removal of bulk contaminants, including host cell proteins and adventitious viruses as well as any potential contaminating leachates from other in-process materials Microfiltration: filtration that can be used at the …

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